On-line authentication of prebiotics or enzyme formulations to ensure source and quality

ABSTRACT

Disclosed is encoding of probiotic and/or prebiotic and/or enzyme formulations, in order to alert both consumer and producer to counterfeiting and to allow purchasers of authentic product to gain access to quality (and probiotic growth and activity) testing of the product. The purchaser would preferably also provide, along with its identifying information, any product complaints, adverse reaction and positive responses, and consumer interest in and reaction to different formulations and products, as well as demographic, general health and education information, and other information about the purchaser (including any information useful for marketing and future product development and selection).

BACKGROUND

Probiotics and prebiotics are a growing sector of the supplementsmarket, estimated to be approaching $2 Billion in sales annually (if oneincludes probiotic fortified foods and desserts, as well as dedicatedsupplement forms such as capsules and tablets). The term “probiotic”typically refers to strains of lactic acid bacteria and bifidobacteria.The specific strains present in probiotic products may vary widely amongdifferent products, as may their quantity, activity and purity.Different products can also lose activity at different rates over time,particularly in the event of temperature fluctuations (particularlyincreases in temperature).

The reported health benefits of probiotics include supporting the immunesystem (inhibiting allergic response and neoplastic growth), treatinginflammatory bowel disease, offsetting lactose intolerance, and reducingcholesterol. They are also useful for repopulating the gut afterantibiotic therapy. Probiotic growth in the intestinal tract, followingingestion, depends to a large extent on the nutrients present in thepatient's diet. Typical human diets are not well suited for probioticsand, given the abundance of and competition from many less fastidiousdigestive tract bacteria (including pathogenic strains such asclostridium, rotaviruses, pathogenic E. coli and Helicobacter pylori) itcan be difficult for probiotics to exponentially multiply in vivo. Tohelp correct this problem, manufacturers of probiotic dietarysupplements often include prebiotics (nutrient substances that encouragethe growth of probiotics in vivo) in their formulations.

Many types of prebiotics are not digested or absorbed in the smallintestine but pass into the colon where they stimulate the growth ofprobiotic bacteria. Fructo-oligosaccharides (FOS) are one type ofprebiotic; inulin compounds (which are also oligosaccharides) areanother. For these compounds to be effective they must be ingested inrelatively large quantities, such as 4-10 grams/day for FOS and 10-14grams/day for inulin. Probiotics, by comparison, can be effectivelyadministered in milligram quantities, containing 10⁷-10¹⁰ colony formingunits (cfu). Thus, it is impractical to mix FOS or inulin withprobiotics and deliver them in capsules or tablets. Further, suchcarbohydrate type prebiotics often break down to glucose, in vivo, whichenhances growth of non-probiotic bacteria, including pathogenicclostridium. Moreover, FOS can cause flatulence and abdominal pain andsome people experience severe allergic reactions to inulin. Therefore,there is a need for a non-carbohydrate prebiotic that can be used at lowdosage while effectively stimulating probiotic bacteria.

Enzymes have been used to generate prebiotics under laboratoryconditions followed by subsequent feeding of the preformed prebiotics toachieve probiotic stimulation (see U.S. Pat. Nos. 6,791,015 and6,730,502). U.S. Pat. No. 5,817,350 discloses the use of the prebioticenzymes cellulase, amylase and hemicellulase, for use as dietarysupplements, though not to stimulate administered probiotics. U.S. Pat.No. 8,945,539 (incorporated by reference) discloses enzymes and fibercombinations which can significantly increase probiotic growth oractivity.

Probiotics, prebiotics and enzymes are marketed as natural supplements,and therefore do not require approval for efficacy against diseases orconditions, by the US Food & Drug Administration (“FDA”) or any othergovernmental agency. The FDA does regulate manufacture, labeling,packaging and holding of these products as set forth in 21 CFR 111,under its authority within the applicable federal laws. Theseregulations, 21 CFR 111, require extensive record-keeping—but do notrequire disclosure of these records to the consumer: only to the FDA.The consumer is mostly unable to verify date of production, or anyquantity or quality testing (i.e., activity and purity) on the productsoffered for purchase. Consumers and retailers are limited to reviewinglabel claims about the strains present and their quantity, or quality.Due to the growth in the market, the leading products are attractivetargets for product counterfeiters, which raises additionalquality-control concerns for the consumer.

Accordingly, a system in allowing verification of the source of theproduct, its quality testing (for quantity, activity and purity) and itsdate of production and/or testing, would offer a significant benefit.

SUMMARY

Following quantity or quality testing, the container or packaging for aprobiotic, prebiotic or enzyme product is encoded, preferably with anRFID tag or with a code (e.g., on a product label) which can be scannedby the purchaser (whether consumer or vendor). The encoding allows thepurchaser to access a website where detailed information about productsis available. For a probiotic product, this information includes testingresults for its number of colony forming units (“CFU”), activity,purity, and possibly other information including its testing date,production date and lot number (among other lots of product). For aprebiotic or enzyme product, this information could include testingresults for their ability to stimulate a probiotic to generate aspecified number of colony forming units (“CFU”) in a unit of time, aswell as purity, and possibly other information including its testingdate, production date and lot number (among other lots of product).

The encoding is also an anti-counterfeiting measure, as the encodedproduct would be associated with its code by the producer at the originin such a way that the scanning of the code by the purchaser would matchthe code logged, if the product is authentic; but otherwise would not.The encoding could be used to alert both consumer and producer tocounterfeiting. That is, if a counterfeit label is detected by mismatch,the product producer could be automatically notified.

The purchaser (whether consumer or vendor) provides its identifying andcontact information to the seller or the producer or formulator or aparty contacted or responsible for the website (all or any of which arereferred to hereinafter as “producer”), either when setting up anaccount on the website or as part of authenticating the encoding. Whenthe purchaser enters or scans the code on the product to authenticatethe product, that would automatically alert both purchaser and theproducer if the label is not recognized (meaning the product iscounterfeit). This information could thereby automatically allowtracking of counterfeit products and their distribution pattern, if, ina more preferred embodiment, the purchaser also entered its location,and the source it purchased from, along with its identifyinginformation. In an even more preferred embodiment, the purchaser wouldalso provide, along with identifying information, any productcomplaints, adverse reaction and positive responses, and interest in andreaction to different formulations and products, as well as demographic,general health and education information, and other information aboutthe purchaser/consumer (including any information useful for marketingand future product development and selection).

One method of obtaining purchaser information is to have a website withthe product information, where in order to access the productinformation, the purchaser provides requested information about itself.It is preferred that this website be separated from other websites ofthe producer, in particular, from any website where product is offeredfor sale. The separation is so that end-user consumers cannot buy anyproduct on the product information website, so that purchasers who aredistributors or retailers do not have their sales (including throughtheir own websites or otherwise) of their products threatened in any wayby the product information website, when its viewed by end-userconsumers. Another option is to provide the purchaser a user ID andpassword for all future product inquiries, after initially providing theidentifying information about itself. That identifying information canthen be used to identify the purchaser, and their location, andpotentially obtain feedback and product reports from the purchaser, asset forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts that when verification of an encoded product fails, theproducer and/or seller is notified; and if the verification indicatesthe product is genuine, the purchaser accesses relevant productinformation.

FIG. 2 depicts that product information can include quality-relatedinformation from all manufacturers of each component in a finalformulation, all of whom make such information accessible to purchasers.

DETAILED DESCRIPTION

Website Configurations

The website where the product information is accessed, and from whichinformation is supplied to the purchaser, is the key component in thesystem described herein. The relationship between the website and thepurchasers can take a number of forms. In one example, the website iscontrolled by a server which is coupled to one or more internet-linkedpurchaser terminals (which may be a personal computer (“PC” or otherwireless computing device) through the Internet. Communication softwareincluding browser software is installed at each purchaser terminal forcommunicating information with server via the HyperText TransferProtocol (“HTTP”) or other internet-link system. The server isidentified by a predetermined Uniform Resource Locator (“URL”) onInternet.

After the establishment of communication connection with the server, thepurchaser terminal is assigned an IP address for identification on theInternet. A user at the purchaser terminal may then communicate with theserver by accessing the aforementioned identifying URL through theInternet.

The website content can be either static or dynamic. A dynamic-contentsite is preferred as it can monitor a changing situation, or provideinformation personalized to the requirements of the individual user. Forexample, the user might have medical conditions or be taking othermedications which can activate the website to issue warnings or advisorymessages. The website can also warn of contaminated product on themarket, or note the most recent quality testing performed on products.The website should also preferably include a searchable feature and beable to respond to user inquiries or concerns, including by allowingmessaging to purchaser by a website user.

Encoding and Analysis

Products, or their labels or packaging or shipment containers, can beencoded by any of several methods, including RFID tags (see, e.g., U.S.Pat. Nos. 7,068,170; 7,336,167; and No. 8,120,466, disclosing encodeddata signals from an RFID tag; all are incorporated by reference). RFIDtags also allow tracking of product location (U.S. Pat. No. 7,336,167).RFID transponders (a/k/a “tags”) have at least two components, anintegrated circuit (IC) chip and an antenna. The chip and antenna can belaminated on plastic cards, encapsulated in protective housings,embedded in label stock, or otherwise displayed in a portable form.

RFID tags can be classified as either active or passive, based on thetag's power source and how the tag sends information to readers. Activetags have an internal transmitter powered by an onboard battery whilepassive tags are powered by an external reader's signal. In a passivetag, the reader's transmission energizes the tag's antenna, which inturn resonates back a corresponding signal.

An RFID reader or interrogator retrieves information stored on a tagthrough a radio frequency signal picked up by the reader's antenna. Anactive reader receives signals broadcast by the tag's internal RFtransmitter. Some active tags broadcast their signals continuouslywithout regard to whether there is a reader within receiving range.Other active tags require a prompt signal from a reader beforebroadcasting their data stream.

A passive reader transmits a signal strong enough to energize the targettag's antenna and circuitry. The tag resonates the signal back to thereader.

Generally, the tag itself cannot incorporate a GPS locator device, dueto size constraints. The location of the tag can be ascertained using aGPS system integrated with the tag reader, as described in U.S. Pat. No.8,253,570, incorporated by reference. In this system, the RFID readerhas RFID radar thereon in order to determine the distance between thereader and the tag. The reader uses a directional antenna such as aYagi-Uda antenna or a parabolic dish antenna in order to dramaticallyincrease the effective range between the reader and the RFID tag. Adigital compass is located on the reader so that once the reader locatesthe RFID tag, the direction to the tag from the reader can bedetermined. A GPS chip is also located on the reader so that once thereader determines the distance and direction to the RFID tag, analgorithm can be employed to determine the exact GPS coordinates for theRFID tag based upon the knowledge of the GPS coordinates for the reader.This system could be used to locate products where RFID tags with GPSlocator are embedded in the product packaging, or in shipment containersfor the products.

RFID tags offer the advantage of secure coding, as well as potentiallyproviding product location, but suffer the disadvantage of being highercost than a simple encoding system, like a bar code. RFID tags must beread by a reader, and it would be impractical to provide a reader toconsumers (though readers could be carried by distributors, retailers orre-sellers of bulk lots of product). One alternative to maintain theadvantages provided by RFID tags with or without a GPS locatorincorporated, is to include them with a shipment of multipleformulations (like, inside a shipping container), and to also haveindividual packages of the formulation further encoded with anotherencoding method, e.g., a scannable code as described below.

Encoding with a bar code or other scannable encoding methods, includesencoding using a QR Code™ (U.S. Pat. No. 5,726,435, incorporated byreference) or other two-dimensional bar code. Scannable encoding ispreferred as it can be readily scanned (with e.g., a cell phone),following which the scanned code can be authenticated through imaging,without further action by any human actor or by the purchaser (i.e., thepurchaser does not need to do any data input, which can lead to mistakesin entry).

Where the purchaser is not the ultimate consumer, such purchaser may beunder a contractual obligation to scan the lot numbers of products whichit receives, for authentication and quality verification. The obligationof such purchaser could be to scan all products labels in a lot, or onlyto scan some sample product labels of each lot. The obligation of suchpurchaser could also be to help others (including end-user consumers)verify authentication and quality on the website. The obligation of suchpurchaser could also be to maintain a web-site portal at their place ofbusiness where product is sold, or allow access to the producer'swebsite through a purchaser website.

The website that the encoding (associated with the product) istransmitted to for authentication would display relevant informationabout the encoded product, including, preferably, the lot number itoriginated from and its date of formulation, as well as growth(generally determined by probiotic CFUs in a plate count) and activity(for probiotics) or induced growth and activity of probiotics (forprebiotics and enzymes), purity, testing date, production date and lotnumber. In the event a non-genuine label is detected, the purchaser andproducer would both be immediately alerted. The consumer wouldpreferably see information on-screen at the website and also receive amessage from the website, asking for help further identify the source ofthe counterfeit product, including preferably the location of the sourceand contact information for the source.

In another example, in the event of sub-standard products or productcontamination, whether accidental or deliberate (like the Tylenolpoisonings of 1982) the localization of such product is facilitated bythe producer having the consumer contact and address, and the source ofthe product, and the source location. This information can be used bythe producer to identify problems with any particular lots of product,including whether the contamination was introduced after production orshipment. This information could be used to aid in quickly removingcontaminated or sub-standard products from the marketplace.

Product purchasers with access to the product information wouldgenerally be either product sellers (distributors or retailers) orend-users (consumers). The purchaser would preferably identify which ofthese categories it is in, as well as its address and contactinformation. Different educational information, or warnings, ormessages, could be provided to the consumer from the website, dependingon which category of purchaser accesses the website. For example,consumer end-users could be provided additional information about thespecific benefits of probiotics for health, as well as any reportedadverse reactions or events reported by other consumers for theformulation or for other probiotic formulations (which consumers wouldalso be queried about and asked to enter). Product seller-purchaserscould be warned to not violate any product agreements or restrictions,including, for example, any restriction on re-selling the products,including those relating to patent or copyright licenses granted to thepurchaser.

As well as providing identifying and contact information in order toaccess product information, purchasers would preferably also enter anagreement with the supplier or producer (on the website) to use thequality information provided about the product only for the purpose ofevaluating the suitability of the product for consumption, and to keepall the product information confidential. Other restrictions onpurchasers could optionally also be included, including advertisingrestrictions, resale pricing and acceptable buyers for the product fromthe purchaser (which might be only consumers or could include downstreamsellers, like retailers), and acceptable channels of distribution (like,direct person to person sales only; internet sales only; mail ordersales only).

In addition to quality testing of the product, other information aboutthe product could also be monitored and provided, directly on thewebsite or by messaging. Such added information could include theproduct storage and shipment conditions, such as temperature, humidity,and time of exposure. Probiotics can degrade if exposed to temperaturesabove refrigeration, or if exposed to temperatures below freezing.Higher humidity generally results in a higher effective temperature ofexposure than the actual ambient temperature (the so-called “heat index”effect). Temperature and humidity logging devices can be included withthe product or the product lot, and follow it through shipment, fortemperature and humidity monitoring. Such logging devices are discussedin U.S. Pat. Nos. 7,392,150 and 5,798,694, incorporated by referenceherein.

Quality, Quantity and Purity Testing

The website accessible by the purchaser provides results of qualityassurance testing for the products' number of colony forming units(“CFU”), activity, purity, and possibly other information including itstesting date, production date and lot number. The lot number isimportant as the quality assurance testing is done by randomly samplingproducts from each lot. The number of products so sampled and testedpreferably should be noted as part of the testing, along with astatistical analysis of the results, including preferably a standarddeviation. The standard deviation should be such that product parameterstested (including CFU, activity, purity) are within one standarddeviation of the claims about the product (including CFUs of probioticbacteria, activity and purity) made on the product label, or otherwisewithin a defined error margin.

The quantity of probiotic bacteria per dose is tested by determining thenumber of colony forming units. The CFU is usually determined by growingbacterial cells into a visible colony on a Petri dish containingappropriate agar for bacterial growth. One visible colony is one CFU,even though a single CFU may contain many bacterial cells or only onecell.

In determining the CFUs, one often overlooked factor that dramaticallyaffects the actual quantity of probiotic which enters the smallintestine, where it can be absorbed and effective, is the fact that theprobiotic experiences significant degradation in the highly acidicenvironment of the stomach. An accurate in vitro determination of CFUswould, therefore, be undertaken following a simulated exposure of theproduct formulation to stomach acid. The acidity of the stomach is aboutpH 1.6, so exposure to such levels for a period approximating the timeof passage through the stomach should be simulated. The time of stomachpassage can be up to 90 minutes, especially if the probiotic formulationis taken with or near the time of food ingestion.

To prevent clumping of the bacteria with other ingredients in theformulation, particularly clumping with enteric coatings such asalginates or gums or other similar ingredients, it has been found thatthe acid around the probiotic formulation should be circulated, in themanner in which the acid in the stomach circulates. A simulation ofstomach acid circulation can be done using a stomacher machine, such asthe Stomacher® 400 Circulator (Seward, Co., UK). Under such conditions,the effective dosage of the probiotic—through determining CFUs obtainedfollowing exposure to a solution of about pH 1.6 in a stomacher—can bereliably determined. The CFUs under such conditions would preferably beposted on the website for access by the purchaser. CFU counts and otherquality analysis can be done internally, or by an outside laboratory.

Other quality checks on the product preferably include activity, growthrate and purity. Growth rate and activity can be determined as describedin U.S. Pat. No. 8,568,712, incorporated by reference. The principle ofgrowth rate determination is that a uniform sample from a flask wherebacteria can feed on growth medium substrate is transferred into aTurbidimeter cell, and greater turbidity indicates greater growth. Thelactic acid production of a sample is also measured, and higherproduction of lactic acid indicates higher bacterial activity.

It should be noted that CFU, growth and activity testing refers to thebacterial probiotic components of the formulations. U.S. Pat. No.8,568,712 discusses selling prebiotics as separate formulations, withoutprobiotics included. Enzymes can also be sold separately fromprobiotics. In such case, the effect of these prebiotics or enzymes onprobiotic growth or activity is part of the relevant qualityinformation; i.e., one would how many CFUs of particular probioticstrains they induce, and whether there is enhanced activity of suchstrains.

Purity testing is for common contaminants and pathogens, including butnot limited to Escherichia coli, Staphylococci, Salmonella and yeast andmold. There are standard tests to determine quantity and presence ofthese contaminants, as set forth in the United States Pharmacopeia andthe Bacteriological Analytical Manual (both incorporated by reference).

Quality Information about Components in the Final Formulation

In the case where the final probiotic formulation consists of multiplecomponents, which are made by different manufacturers, the verificationsystem described herein can be expanded so that the quality analysis andinformation for all components is available to the purchaser. Theseadded components might include one or more strains of the lactobacillusor bifidobacterium in the formulation, enteric coating components (suchas alginate or xanthan gum), polysorbate 80, polysorbate 60 (see U.S.Pat. No. 8,066,986, incorporated by reference) oleic acid, lecithin (seeU.S. Pat. No. 8,105,577, incorporated by reference), enzymes (includingα-galactosidase and β-glucanase), prebiotics (including iso-maltooligosaccharides, see U.S. Pat. No. 8,568,712, incorporated byreference) partially hydrolyzed guar gum, inulin and dextrin, and othercarriers, binders or adsorbents, including but not limited to food gradestarches and silicates. The above formulations can be packaged foradministration in capsules, tablets or packets, or combinations thereof.Alternatively, they can be added to foods (including yogurt and dairyproducts, desserts, cereals, and breads), separately or in combination,to enhance growth and activity of indigenous probiotic bacteria.

Where the final probiotic formulation consists of multiple components,the manufacturer of each component would preferably post its qualityanalysis on the website accessible by the purchaser. As an example, themanufacturer(s) of probiotic bacteria in the product would analyze (bylot) and post the results of that analysis. The manufacturer of anyenzymes or prebiotics would also analyze by lot and post those results.The manufacturers could also be obligated by agreement to include allsuch information and to cooperate in posting of results to the website.The final formulation results would include the lot number of allcomponents in it, so all analyses can be viewed by the purchaser. SeeFIG. 2.

All testing of all components should preferably include a statisticalanalysis of the results, including at least a standard deviation. Thestandard deviation should preferably be such that product parameterstested are within one standard deviation of the claims about the productmade on the product label.

Adverse Events, Positive Results and Marketing Information

The end user-consumer would, when accessing the website with productinformation, preferably also be queried about product complaints,adverse reaction and positive responses, and consumer interest in andreaction to different formulations and products, as well as demographic,general health and education information, and other purchaser andinformation (including any information useful for marketing and futureproduct development and selection).

In the event of complaints, side effects or adverse reactions, orpositive responses, the consumer would be asked to provide informationabout race, ethnicity, other natural supplements and drugs consumed,diet, alcohol consumption, and blood type or HLA typing results (ifknown). In a further analysis, the consumer could provide body fluidsamples or swabs for genetic analysis. The foregoing factors couldaffect the consumer's reaction to the product, and isolation of whichfactors are involved in such reactions could be determined bycompilation and analysis of such consumer information. Theidentification of factors involved in positive and adverse reactionscould also be used by the producer for product design. For example, if apopulation is identified which cannot tolerate a particular bacterialstrain or prebiotic component, a product without such strains orcomponents could be designed for sale to that population. Similarly, ifparticular foods or substances are identified with adverse reactions,warning labels could be placed on the product label to not consume themwith the product.

All such consumer information can be compiled and analyzedstatistically, in determining efficacy or adverse events about theproduct. For example, there could be a threshold for the number of sideeffects which need to be reported before a side effect is deemedsignificant enough to warrant adding a warning label for any particularpopulation.

Consumers could also be encouraged to report complaints, side effects oradverse reactions, or positive responses, by contract with the partycontrolling the website, for example, entered at the time of initiallyactivating an account on the website. Or, consumers could be provided areward system (such as a discount on buying future products) for makinga report. The rewards could be in electronic or printed form.

A reward system could also be used to encourage consumers and otherpurchasers to provide their identifying information, and otherinformation along with the product code. The website would monitor andcontrol the rewarding system, and awarding of rewards to consumers. Inthis way, the producer, through the website, promotes authenticating ofall its products in commerce, and helps reduce counterfeiting.

A reward system can be tailored to as to encourage consumers to purchaseexcess inventory (by increasing the total number of rewards distributedor increasing their value in reimbursement for product purchase). Suchreward system can also reduce sales in the event supplies of product runlow. The precise adjustment to the rewards in any of these cases couldbe performed by heuristic methods or the methods associated with pricingscience, as a demand optimization problem, where the production ofproduct is limited.

The specific methods and compositions described herein arerepresentative of preferred embodiments and are exemplary and notintended as limitations on the scope of the invention. Other objects,aspects, and embodiments will occur to those skilled in the art uponconsideration of this specification, and are encompassed within thespirit of the invention as defined by the scope of the claims. It willbe readily apparent to one skilled in the art that varying substitutionsand modifications may be made to the invention disclosed herein withoutdeparting from the scope and spirit of the invention. The inventionillustratively described herein suitably may be practiced in the absenceof any element or elements, or limitation or limitations, which is notspecifically disclosed herein as essential. Thus, for example, in eachinstance herein, in embodiments or examples of the present invention,any of the terms “comprising”, “including”, containing”, etc. are to beread expansively and without limitation. The methods and processesillustratively described herein suitably may be practiced in differingorders of steps, and that they are not necessarily restricted to theorders of steps indicated herein or in the claims. It is also noted thatas used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural reference, and the plural include singularforms, unless the context clearly dictates otherwise. Under nocircumstances may the patent be interpreted to be limited to thespecific examples or embodiments or methods specifically disclosedherein. Under no circumstances may the patent be interpreted to belimited by any statement made by any Examiner or any other official oremployee of the Patent and Trademark Office unless such statement isspecifically and without qualification or reservation expressly adoptedin a responsive writing by Applicants.

The invention has been described broadly and generically herein. Each ofthe narrower species and subgeneric groupings falling within the genericdisclosure also form part of the invention. The terms and expressionsthat have been employed are used as terms of description and not oflimitation, and there is no intent in the use of such terms andexpressions to exclude any equivalent of the features shown anddescribed or portions thereof, but it is recognized that variousmodifications are possible within the scope of the invention as claimed.Thus, it will be understood that although the present invention has beenspecifically disclosed by preferred embodiments and optional features,modification and variation of the concepts herein disclosed may beresorted to by those skilled in the art, and that such modifications andvariations are considered to be within the scope of this invention asdefined by the appended claims.

What is claimed is:
 1. A method of verifying the authenticity andquality of a formulation including prebiotics and other componentspurchased from a producer, comprising: encoding the formulation with acode that can be scanned and transmitted to a website controlled by theproducer; receiving the scanned code at the website for authenticationof the code; and providing information from the website, followingauthentication, about quality and purity testing on the formulation; or,if authentication fails, alerting the producer to said authenticationfailure.
 2. The method of claim 1 wherein the formulation includesprobiotics and the information provided from the website includesprobiotic growth and activity.
 3. The method of claim 1 wherein the codeis a two-dimensional bar code imprinted on a label on the formulationpackaging.
 4. The method of claim 1 further including providing apurchaser of the formulation information from the server, followingauthentication, including the lot number of the formulation and its dateof production.
 5. The method of claim 4 further including providing thepurchaser information from the server, following authentication, aboutquality testing of the other components in the formulation.
 6. Themethod of claim 5 wherein the information about the quality testing ofthe other components in the formulation is provided by the manufacturersof the components.
 7. The method of claim 4 further including the serverrequesting information from the purchaser.
 8. The method of claim 7further including the server requesting from the purchaser whether itintends to sell the formulation to a third party or consume theformulation itself.
 9. The method of claim 7 wherein the informationabout the purchaser includes its address and contact information. 10.The method of claim 7 wherein the information includes the source of theformulation, and contact information for the source.
 11. The method ofclaim 4 further including the server requesting the purchaser to scanthe code.
 12. The method of claim 4 further including providing thepurchaser information about benefits of probiotics for health, and anyreported adverse events or reactions from probiotics or from theformulation.
 13. The method of claim 12 wherein the information isprovided after the purchaser is authenticated by the website.
 14. Amethod of verifying the authenticity and quality of a formulationincluding prebiotics and other components purchased from a producer,comprising: encoding the formulation using a scannable code or an RFIDtag wherein encoded information can be scanned and transmitted to aserver controlled by the producer or a third party; and authenticatingthe code or the RFID tag by the server; providing information from thewebsite about quality and purity testing on the formulation; unlessauthentication fails, in which case, the producer or third party isalerted to said authentication failure.
 15. The method of claim 14wherein the formulation includes probiotics and the information providedfrom the website includes probiotic growth and activity.
 16. The methodof claim 14 wherein a purchaser scans the information and is granted thelot number of the formulation and its date of production, uponauthentication.
 17. The method of claim 16 further including providingthe purchaser information from the server, following authentication,about quality testing of the components in the formulation.
 18. Themethod of claim 17 wherein the information about the quality testing ofthe components in the formulation is provided by the manufacturers ofthe components.
 19. The method of claim 17 further including the serverrequesting the purchaser to scan the code.
 20. The method of claim 17wherein in the event that authentication fails, the purchaser is queriedto identify the source of the formulation, and contact information forthe source.
 21. The method of claim 17 wherein a two-dimensional barcode is imprinted on a label on the formulation packaging.
 22. Themethod of claim 16 further including the server requesting informationfrom the purchaser.
 23. A method of verifying the authenticity andquality of a formulation including enzymes and other componentspurchased from a producer, comprising: encoding the formulation with acode that can be scanned and transmitted to a website controlled by theproducer; receiving the scanned code at the website for authenticationof the code; and providing information from the website, followingauthentication, about quality and purity testing on the formulation; or,if authentication fails, alerting the producer to said authenticationfailure.
 24. The method of claim 23 wherein the formulation includesprebiotics and probiotics and the information provided from the websiteincludes probiotic growth and activity.
 25. The method of claim 23wherein the code is a two-dimensional bar code imprinted on a label onthe formulation packaging.
 26. The method of claim 23 further includingproviding a purchaser of the formulation information from the server,following authentication, including the lot number of the formulationand its date of production.
 27. The method of claim 26 further includingproviding the purchaser information from the server, followingauthentication, about quality testing of the other components in theformulation.
 28. The method of claim 27 wherein the information aboutthe quality testing of the other components in the formulation isprovided by the manufacturers of the components.
 29. The method of claim26 further including the server requesting information from thepurchaser.
 30. The method of claim 26 further including the serverrequesting the purchaser to scan the code.
 31. The method of claim 30further including the server requesting from the purchaser whether itintends to sell the formulation to a third party or consume theformulation itself.
 32. The method of claim 30 wherein the informationabout the purchaser includes its address and contact information. 33.The method of claim 30 wherein the information includes the source ofthe formulation, and contact information for the source.
 34. The methodof claim 26 further including providing the purchaser information aboutbenefits of probiotics for health, and any reported adverse events orreactions from probiotics or from the formulation.
 35. The method ofclaim 34 wherein the information is provided after the purchaser isauthenticated by the website.
 36. A method of verifying the authenticityand quality of a formulation including enzymes and other componentspurchased from a producer, comprising: encoding the formulation using ascannable code or an RFID tag wherein encoded information can be scannedand transmitted to a server controlled by the producer or a third party;and authenticating the code or the RFID tag by the server; providinginformation from the website about quality and purity testing on theformulation; unless authentication fails, in which case, the producer orthird party is alerted to said authentication failure.
 37. The method ofclaim 36 wherein the formulation includes probiotics and the informationprovided from the website includes probiotic growth and activity. 38.The method of claim 36 wherein a purchaser scans the information and isgranted the lot number of the formulation and its date of production,upon authentication.
 39. The method of claim 38 further includingproviding the purchaser information from the server, followingauthentication, about quality testing of the components in theformulation.
 40. The method of claim 39 wherein the information aboutthe quality testing of the components in the formulation is provided bythe manufacturers of the components.
 41. The method of claim 36 furtherincluding the server requesting information from the purchaser.
 42. Themethod of claim 38 further including the server requesting the purchaserto scan the code.
 43. The method of claim 38 wherein in the event thatauthentication fails, the purchaser is queried to identify the source ofthe formulation, and contact information for the source.
 44. The methodof claim 38 wherein a two-dimensional bar code is imprinted on a labelon the formulation packaging.